Raw Data & Data Integrity
Im Auftrag der ECA Academy

Programm

Raw Data - Understanding, Defining and Managing

Cutting Through the Confusion and Fog of Regulatory Terms
Currently there are many terms used in GMP regulations and data integrity guidance documents. What do they mean? How are they relevant to debate? Definition and interpretation of

• Original record / record
• Raw data – MHRA GMP and US GLP definitions
• Data and metadata
• True copy
• Complete data
• Initial data
• Translating raw data for a GMP environment: should we treat manufacturing and laboratory the same when it comes to raw data?

Interpretation of Raw Data for Production Systems
Using a manufacturing process that is automated by standalone PLCs, PLCs linked to a SCADA system and an automated Manufacturing Execution System, what constitutes raw data will be outlined.

Raw Data for PLCs

PLCs linked to a SCADA system

SCADA linked to a Manufacturing Execution System

Interpretation of Raw Data for Laboratory Systems
Using a process involving a chromatography data system and a LIMS, what constitutes raw data will be outlined in two scenarios

• Hybrid CDS and manual input to the LIMS
• Electronic CDS with automatic transfer to the LIMS
• Managing sample management and preparation records

Can a True Copy be Raw Data?
This brief presentation will start from the definitions of raw data and true copy and explore if and how a true copy can be considered raw data.

Workshop: Defining Raw Data for Production, QA and Laboratory Systems
This workshop is intended to reinforce the

Data Integrity - Requirements for a GMP-compliant Data Life Cycle

Why is Data Integrity Important? – Setting the Scene

• Summary of falsification observed by FDA and EU inspectors 2005 – to date
• FDAISA act 2012 and October 2014 Guidance for Industry and the impact on inspections
• Inspection of computerised systems is changing: from paper to on-line
• MHRA expectation for data governance; data integrity guidance documents 2016
• FDA Level 2 guidance on data integrity: 2010 and 2014 postings
• Impact of WHO guidance for data integrity

Data Integrity – EU GMP Requirements

• EU GMP Chapter 4 – documentation
• EU GMP Annex 11 computerised systems
• Data integrity definitions
• Difference between paper and electronic systems

Principles of Data Integrity

• The ALCOA+ criteria for data integrity
• Data life cycle in the process workflow – managing controls
• Paper versus hybrid versus electronic systems
• Validation of computerised systems for data integrity controls
• Scope: production information versus laboratory data: why are laboratory data higher risk?

WHO, MHRA and GAMP Data Integrity Guidances - Key Points

• Data Governance System within the Pharmaceutical Quality System
• Data Life Cycle
• Spectrum of Systems: Paper to Electronic Systems with data integrity audit
• The GAMP Records and Data Integrity Guide

FDA Draft Guidance for Industry ‘Data Integrity and Compliance with cGMP’

• Background
• Questions and Answers regarding Data Integrity

Role of Management in Data Integrity

• Role of Senior, Production and Department Management in ensuring data integrity within an organisation and its suppliers
• Data governance within a Quality System
• Failures to address poor data integrity practices and no training

Development and Scope of a Data Governance System

• Within a PQS, what is the scope of a data governance system?
• Who are involved?
• What are their roles?

Implementing Data Integrity Training

• Scope of data integrity training
• What cover in the training?
• Checking training effectiveness
• Integrating data integrity training with GMP training

US 21 CFR 211 and EU GMP Chapter 4: Complete data vs raw data vs primary record

• Why complete data and raw data are important for understanding data integrity
• EU GMP Chapter 4 requirements for raw data
• 21 CFR 211 requirements for laboratory records: complete data
• FDA Level 2 guidance: paper versus e-records
• Complete data / raw data / primary record example

Ensuring Data Integrity in a Chromatography System

• Configuration of CDS software
• SOP for integration
• Using samples for testing the System

Audit Trails and their Review

• Understanding Annex 11 requirements for audit trails
• Differences between Part 11 and Annex 11 requirements for audit trail
• Default comments versus free text as reasons for change
• Review of audit trail entries: how to comply with Annex 11
• Reality v regulation: are audit trails in commercial products ready for Annex 11?

User Account Management and Application Configuration

• Separation of roles and responsibilities between IT and the business
• Documentation of the configuration of an application e.g. audit trail, user types and access privileges
• User account management: the dos and don’ts
• User identities must be unique
• Regular review of each system users and privileges

IT Support for Data Integrity

• IT facilities, environmental controls and physical security
• Qualified IT infrastructure and validated IT systems
• Backup and recovery / Change control
• IT support including database administration
• Impact of IT infrastructure on data integrity

GMP meets the Cloud

• Regulatory compliance requirements to consider before going to the cloud
• Are ISO 27001 or SSAE 16 adequate to meet GMP regulations?
• Whose responsibility is data integrity when using the cloud?
• Cloud suppliers: are you dealing with a single entity?
• How to select a cloud supplier

Supply Chain Data Integrity

• Approaches to ensuring data integrity of your suppliers
• Role of technical agreements and audits

Key Learning Points and Final Discussion

• Summary of Data Integrity Requirements and Key Learning Points
• Final Discussions and close of the course